FDA 510(k)

BIOTEQ 引流导管套装（一步式类型）

K号: K200103 · 2020-10-09

决定日期2020-10-09

产品代码FGE

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决定实质等同

器械摘要

BIOTEQ Drainage Catheter Set (One Step Type) is the device name listed in this FDA 510(k) record. The listed applicant is Bioteque Corporation. It received FDA 510(k) clearance on 2020-10-09 under 510(k) number K200103. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BIOTEQ Drainage Catheter Set (One Step Type)?

BIOTEQ Drainage Catheter Set (One Step Type) is a medical device that received FDA 510(k) clearance on 2020-10-09. The listed applicant is Bioteque Corporation. The 510(k) number is K200103.

When did BIOTEQ Drainage Catheter Set (One Step Type) receive FDA 510(k) clearance?

BIOTEQ Drainage Catheter Set (One Step Type) received FDA 510(k) clearance on 2020-10-09, under 510(k) number K200103.

Who is the listed applicant for BIOTEQ Drainage Catheter Set (One Step Type)?

The FDA 510(k) record lists Bioteque Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOTEQ Drainage Catheter Set (One Step Type)?

The FDA product code for BIOTEQ Drainage Catheter Set (One Step Type) is FGE.

列明Bioteque Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251019BIOTEQ 引流导管套装：BT-PD1-SERIES-G 和 BT-PDS-SERIES-G K210419BIOTEQ 引流导管 BT-PDS系列

相关器械（代码：FGE）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254179引流导管Canyon Medical, Inc.K262913Protégé™ EverFlex™ 自膨胀外周支架系统Medtronic, Inc.K260835阿基米德可生物降解支架（中号）Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)K253393一次性球囊扩张导管（AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019）Hangzhou AGS MedTech Co., Ltd.K253832扩张球囊导管Mirco-Tech (Nanjing) Co., Ltd.K251658Endoflux® 胆管与胰腺支架套装Medi-Globe GmbH

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